Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Brief Summary

Official Title: “A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures”

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2010

Interventions Used in this Clinical Trial

  • Drug: BGG492
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: BGG492
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
    • Time Frame: 28 days
      Safety Issue?: No

Secondary Measures

  • Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
    • Time Frame: 28 days
      Safety Issue?: No
  • Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks
    • Time Frame: 12 weeks
      Safety Issue?: Yes
  • Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)
    • Time Frame: 10 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Outpatients ≥ 50 kg (110 lb) of weight
  • A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures
  • Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.
  • Treated with a stable dose of 1-2 AEDs
  • At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
  • No 28-day seizure-free period during the 8 weeks preceding randomization
  • Positive biomarker screening

Exclusion Criteria

  • Presence of only non-motor simple partial seizures
  • History of psychogenic seizures
  • Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
  • Previous history of Lennox-Gastaut syndrome
  • Pregnant or nursing (lactating) women
  • Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01167335